Final report for vacuum therapy in primary wound healing published by IQWiG in Germany

The Institute for Quality and Efficiency in Health Care (IQWiG) has presented its second final report on the benefit assessment of vacuum therapy in wounds healing. The previous final report for vacuum therapy in the wounds healing by secondary intention was published by IQWiG in late March 2019.

The subject matter of the current final report is the intended primary wound healing, i.e. the treatment of wounds, as they typically occur during operation.

In the case of the vacuum therapy, the wound is covered airtight with a bandage with a pump connected via a thin tube. The pump constantly removes the wound fluid, creating a negative pressure in the wound area. This is intended to increase blood circulation in the wound. In addition, the wound remains moist, which should also promote healing.

The vacuum therapy is used, among other things, in difficult-to-heal or large-area wounds, for example in patients with decubitus (bedsores) or during the postoperative period. Experts speak of an intended primary wound healing when the wound edges are flush and can be sewn together, as it is for example after an operation. In secondary wound healing, on the other hand, tissue must be reformed, the wound contracted, or skin transplanted.

A systematic literature search for primary literature sources was carried out in the databases MEDLINE, Embase and Cochrane Central Register of Controlled Trials. In parallel, a search for relevant systematic reviews was carried out in the databases MEDLINE, Embase, Cochrane Database of Systematic Reviews and HTA Database. For the final report on primary wound healing, the institute accessed usable data from a total of 45 studies (12 of which were randomized controlled trials (RCTs) and the rest 16 – not randomized studies).

These studies compared the vacuum therapy in patients with acute and chronic wounds of different origin with a conventional form of wound care. Postoperative wounds were examined in endoprosthetics (joint replacement), obstetrics (as a result of caesarean section), in abdominal, vascular and cardiac surgery. The majority of the studies presented cases with an increased risk of wound healing disorders. In these studies, a total of 1082 patients were described, 596 patients in the RCTs and 486 in the nonrandomized ones.

Results:

• Wound healing: positive wound healing results were reported in 4 studies (the data was obtained at the 6 weeks (42 days) trim point) with moderate qualitative reliability. There was a statistically significant difference between the treatment groups in favor of vacuum therapy (OR 2.54, 95% CI [1.35, 4.79])
• Therapy complications - reinterventions: results for the rate of reinterventions was reported in 23 studies. In the joint evaluation of the studies with moderate and high qualitative reliability of results, a statistically significant difference in favor of vacuum therapy was found (OR 0.71 (95% CI [0.51; 0.99])
• Therapy complications - infection: 36 studies reported results regarding infection. In the meta-analysis, there was a statistically significant difference in favor of vacuum therapy in both high qualitative reliability studies (CE / US / 11/01 / PIC, Gillespie 2015, IMS trial, NEPTUNE, S-20130010 and The DRESSING Trial; OR 0.59, 95% CI [0.37, 0.93]), as well as considering the totality of all studies (OR 0.62, 95% CI [0.52, 0.74])
• However, there was no statistically significant difference in the joint evaluation of the studies with moderate and high qualitative reliability of results regarding the mortality, time to wound healing, therapy complications such as bleeding and overall rate of complications, pain, length of hospital stay, duration of stay in the intensive care unit, rehospitalization, health-related quality of life and function. Also, no results were obtained regarding amputation as the treatment complication, as well as regarding dependence on outside help or long-term care.

As a conclusion, the institute certifies the vacuum therapy method with a higher benefit compared to conventional wound care. However, IQWiG's Director outlined that statements about benefit and harm of vacuum therapy are in part uncertain as the study leaders keep results under wraps, even though some studies were completed more than 10 years ago.

The full details in German can be found here.

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